Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)

Phase 3

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002224
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. The purpose of this study is to compare the effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).

Detailed Description

Patients are randomized to 1 of 2 open-label treatment groups. Group 1 receives ddI EC plus d4T plus NLF for 48 weeks. Group 2 receives ddI plus d4T plus NLF for 48 weeks. Both forms of ddI are administered orally once daily. Antiviral activity is determined by the magnitude and the duration of reduction of plasma HIV RNA from baseline through Week 24.

Study Timeline

• Study Start: 1999-03
• Primary Completion: 1999-03
• Study Completion: 1999-03
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2011-04
• Disposition First Submitted: 2011-04-13
• Disposition First Submitted QC: 2011-04-13
• Last Update Submitted: 2011-04-13
• Disposition First Posted: 2011-04-25
• Last Update Posted: 2011-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (23)

Chicago Ctr for Clinical Research; 🇺🇸 Chicago, Illinois, United States

Univ of Kansas School of Medicine; 🇺🇸 Wichita, Kansas, United States

Beacon Clinic / Boulder Community Hosp; 🇺🇸 Boulder, Colorado, United States

Community Health Care; 🇺🇸 Fort Lauderdale, Florida, United States

Immunity Care and Research Inc; 🇺🇸 Fort Lauderdale, Florida, United States

Sorra Research Ctr / Med Forum; 🇺🇸 Birmingham, Alabama, United States

AIDS Research Consortium of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Oak Lawn Physicians Group; 🇺🇸 Dallas, Texas, United States

Swedish Med Ctr; 🇺🇸 Seattle, Washington, United States

Univ of Texas Southwestern Med Ctr of Dallas; 🇺🇸 Dallas, Texas, United States

Houston Clinical Research Network / Div of Montrose Clinic; 🇺🇸 Houston, Texas, United States

Robert Scott MD; 🇺🇸 Oakland, California, United States

Anderson Clinical Research Inc; 🇺🇸 Reading, Pennsylvania, United States

Clinique Medicale du Quartier Latin; 🇨🇦 Montreal, Quebec, Canada

Saint Josephs Comprehensive Research Institute; 🇺🇸 Tampa, Florida, United States

HIV Clinical Research Ctr; 🇺🇸 Fort Lauderdale, Florida, United States

South Shore Hosp; 🇺🇸 Miami, Florida, United States

Clinical Studies of Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

Nicholaos Bellos; 🇺🇸 Dallas, Texas, United States

Clinique Medicale L'Actuele; 🇨🇦 Montreal, Quebec, Canada

Univ of Nebraska Med Ctr; 🇺🇸 Omaha, Nebraska, United States

Coastal Carolina Research Ctr; 🇺🇸 Mount Pleasant, South Carolina, United States

AIDS Healthcare Foundation; 🇺🇸 Los Angeles, California, United States